Washington Editor

WASHINGTON - Pulling back slightly from an earlier plan, the National Institutes of Health last week unveiled final conflict-of-interest regulations on its employees, which turned out to be less restrictive than those first enacted six months ago.

The new restrictions vary, depending on the employee's role at the public health agency. For example, senior management and others who play roles in research decisions must meet a higher standard of disclosure and divestiture than those who don't. Such a concession, which is less limiting than rules put in place in February, reflects thinking that NIH employees must be allowed interaction with professional associations, participation in public health activities and genuine teaching opportunities to advance science and keep on the cutting edge of research.

"Our research should be based on scientific evidence that is not influenced by any other factors," NIH Director Elias Zerhouni said during a conference call. "The trust of the public and the ability for us to provide scientific advice that's untainted is the No. 1 goal of all of our efforts."

The final rules still prohibit outside consulting by NIH staff to substantially affected organizations, such as pharmaceutical, biotechnology or medical device manufacturing companies, health care providers or insurers and supported research institutions.

But a number of caveats are built into the remainder of the guidelines, based largely on employee status.

All senior employees, a group of about 200 that includes Zerhouni, the heads of each institute and others with decision-making responsibilities, must divest all $15,000-plus holdings per company in organizations that do business with the NIH. That rule also applies to their spouses and minor children. Other employees also could be required to divest if, after review, a potential conflict resulting from their holdings or those of their spouses and minor children would impede their ability to do their government job.

Outside monetary awards will continue to be contingent upon prior approval and be limited to awards that are determined through a pre-screening process. The regulations will bar senior employees from receiving cash components of such awards offered by donors who have matters pending under their official responsibility.

Employees who file either public or confidential financial disclosure reports, and those non-filers who serve as clinical investigators identified on an NIH clinical study, are required to report their interests in organizations that do business with the NIH, as well as those of their spouse and minor children, and to indicate the amount held in such investments.

Lastly, to facilitate academic and scientific interactions, the final regulations will allow outside activities with professional or scientific organizations, service on data and safety monitoring boards, lectures and scientific grant review, as well as maintaining current provisions that permit NIH scientists to engage in compensated academic outside activities, such as teaching courses at universities, writing general textbooks, performing scientific journal reviews or editing and providing general lectures as part of continuing professional education programs. NIH scientists also can engage in the practice of medicine and other health professions with prior approval and in accordance with existing rules.

Zerhouni stressed that the final guidelines reflect an effort aimed at "our ability to continue to attract and retain the best scientists and staff."

The regulations were developed by the Department of Health and Human Services, in close collaboration with NIH, and with the concurrence of the Office of Government Ethics, the federal agency that prescribes executive branch-wide ethics standards. The rules also follow comments about the interim ethics regulation submitted by NIH staff, the public and scientific organizations.

"We've done what we said we would do, and that is that we would listen and reach at the end what is the right way to serve the public," Zerhouni said. "That's to have a set of rules that absolutely and positively protect the integrity of the agency, while at the same time not imposing burdens that are not necessary to maintain the mission of the agency."

The NIH is made of 27 institutes and centers and is a component of the U.S. Department of Health and Human Services.

FDA Warns On False Promotions

The agency recently has issued a number of charges for false or misleading advertising, and the latest is directed at SuperGen Inc.'s Nipent (pentostatin).

The FDA warned the Dublin, Calif.-based company that material distributed with the leukemia drug fail to present any risk information, contain an unsubstantiated claim regarding the mechanism of action of the drug and overstate its safety and efficacy. By doing so, the agency added that SuperGen is "misleadingly" suggesting Nipent is safer or more effective than has been demonstrated.

The company was asked to immediately cease disseminating the promotional material. Second-quarter sales of Nipent totaled about $3.4 million for the period ended June 30.

Other recent FDA charges of false or misleading material were directed at Fuzeon (enfuvirtide, from F. Hoffmann-La Roche Ltd.), Quadramet (samarium SM 153 lexidronam, from Cytogen Corp.), Survanta (beractant, from Abbott Laboratories), Tracleer (bosentan, from Actelion Ltd.) and Zyvox (linezolid, from Pfizer Inc.).

Plan B Contraceptive Delays Persist

The FDA is refusing to take action on an application to make the Plan B contraceptive product available over the counter as it begins to weigh the potentially precedent-setting matter through an open public process.

Barr Laboratories Inc., of Woodcliff Lake, N.J., has applied for over-the-counter status for women 16 and older, while it would remain available only by prescription for those under that age. The agency indicated that its holdup is related to issues surrounding such dual sales categories.

"The agency is unable at this time to reach a decision on the approvability of the application," FDA Commissioner Lester Crawford said Friday in a statement, "because of these unresolved regulatory and policy issues that relate to the application we were asked to evaluate."

He was criticized during his Senate confirmation process for the agency's slow handling of the issue, including charges that conservative ideology was trumping science.

In the 1980s, the FDA first allowed a prescription-only product to also be sold over the counter, but it involved a different indication. To date, no prescription-only product is also sold over the counter for the same indication.

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